Talk to your doctor about FASLODEX with IBRANCE® (palbociclib)

FASLODEX is a prescription medicine used to treat women with:

  • HR-positive, HER2-negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), in combination with IBRANCE® (palbociclib) in women whose disease has progressed after endocrine therapy

Is FASLODEX with IBRANCE right for you?

If you…

  • Have received a diagnosis of advanced or metastatic breast cancer and…
  • Your breast cancer is HR-positive, HER2-negative and…
  • Your cancer has spread after previous endocrine therapy…

…then you and your doctor may consider whether FASLODEX with IBRANCE is right for you.

When your doctor makes treatment decisions, he or she may also think about whether you have anything in common with the women in clinical studies. You may recognize things you have in common with the women below.

Based on these factors and more, you and your doctor can talk about whether FASLODEX with IBRANCE is right for you. Talk to your doctor about what you may have in common with the women in the PALOMA-3 study.

paloma_study

Women in the PALOMA-3 study*

If you have been through menopause or have been given medication that begins menopause, you may still have something in common with the women in this study. You do not need to have gone through menopause to be considered for this medication.

All (100%) women in the PALOMA-3 study experienced disease progression during or after prior endocrine therapy.

Most (75%) women in the PALOMA-3 study were previously given chemotherapy.

In the PALOMA-3 study, breast cancer spread to the following locations:

  • Organs, such as liver or lungs (60% of women)
  • Bone only (23% of women)

Women in the PALOMA-3 study had cancer that spread to 1-3 or more locations.

If your advanced or metastatic breast cancer has spread to any of the above locations, talk to your doctor about how FASLODEX with IBRANCE may be able to help.

HER2=human epidermal growth factor receptor 2; HR=hormone receptor.

*Patients studied in PALOMA-3 consisted of 521 women with advanced or metastatic breast cancer who had disease progression on or after previous endocrine therapy.

The PALOMA-3 study was not designed to suggest use in patients with specific disease characteristics, although you may have some things in common with the women in the study. The PALOMA-3 results applied to all patients in the study.

You should not receive FASLODEX if you have had an allergic reaction to fulvestrant or any of the ingredients in FASLODEX. Symptoms of an allergic reaction to FASLODEX may include itching or hives; swelling of your face, lips, tongue, or throat; or trouble breathing.

The most common side effects observed in PALOMA-3 included infections; tiredness; nausea; decreased red blood cells, white blood cells, and/or platelets; sore mouth; headache; diarrhea; constipation; vomiting; sudden hair loss; rash; loss of appetite; and fever.

When FASLODEX is used in combination with IBRANCE, also read the IBRANCE Patient Information.

IMPORTANT SAFETY INFORMATION ABOUT FASLODEX® (fulvestrant) injection

    You should not receive FASLODEX if you have had an allergic reaction to fulvestrant or any of the ingredients in FASLODEX. Talk to your health care provider if you experience symptoms of an allergic reaction to FASLODEX, which may include itching or hives; swelling of your face, lips, tongue, or throat; and trouble breathing.

    Before receiving FASLODEX, tell your health care provider about all of your medical conditions, including if you:

  • Have a low level of platelets in your blood or bleed easily. Especially, tell your health care provider if you take a blood thinner medicine (anticoagulant)
  • Have liver problems
  • Are pregnant or plan to become pregnant, because FASLODEX can harm your unborn baby. Your health care provider may perform a pregnancy test within 7 days before starting FASLODEX. Women who are able to become pregnant should use effective birth control during treatment with FASLODEX and for 1 year after the last dose. Tell your health care provider right away if you become pregnant or think you are pregnant while on FASLODEX
  • Are breastfeeding or plan to breastfeed. It is not known if FASLODEX passes into breast milk. Do not breastfeed during treatment with FASLODEX and for 1 year after the final dose. Talk to your health care provider about the best way to feed your baby during this time

Tell your health care provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. FASLODEX may affect the way other medicines work, and other medicines may affect how FASLODEX works.

FASLODEX is administered by your health care provider as an injection into the muscle of each buttock. Your health care provider may change your dose of FASLODEX if needed.

FASLODEX may cause serious side effects, including injection site–related nerve damage. Call your health care provider if you develop any of the following symptoms in your legs following a FASLODEX injection: numbness, tingling, or weakness.

Common side effects of FASLODEX include injection site pain; nausea; muscle, joint, and bone pain; headache; back pain; tiredness; pain in arms, hands, legs or feet; hot flashes; vomiting; loss of appetite; weakness; cough; shortness of breath; constipation; increased liver enzymes; and diarrhea.

Tell your health care provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with FASLODEX. For more information, ask your health care provider or pharmacist. You may report side effects to the FDA at 1-800-FDA-10881-800-FDA-1088.

Approved Uses for FASLODEX

FASLODEX is a prescription medicine used to treat advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic).

FASLODEX may be used alone, if you have gone through menopause, and your advanced breast cancer is:

  • hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative and has not been previously treated with endocrine therapy

or

  • HR-positive and has progressed after endocrine therapy

FASLODEX may be used in combination with ribociclib, if you have gone through menopause, and your advanced or metastatic breast cancer is HR-positive and HER2-negative, and has not been previously treated with endocrine therapy or has progressed after endocrine therapy.

FASLODEX may be used in combination with palbociclib or abemaciclib if your advanced or metastatic breast cancer is HR-positive and HER2-negative, and has progressed after endocrine therapy.

When FASLODEX is used in combination with palbociclib, abemaciclib or ribociclib, also read the Patient Information for the prescribed product.

It is not known if FASLODEX is safe and effective in children or in people with severe liver problems.

Please see FASLODEX Prescribing Information with Patient Information.

 
 
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IMPORTANT SAFETY INFORMATION ABOUT FASLODEX® (fulvestrant) injection

    You should not receive FASLODEX if you have had an allergic reaction to fulvestrant or any of the ingredients in FASLODEX. Talk to your health care provider if you experience symptoms of an allergic reaction to FASLODEX, which may include itching or hives; swelling of your face, lips, tongue, or throat; and trouble breathing.

    Before receiving FASLODEX, tell your health care provider about all of your medical conditions, including if you:

  • Have a low level of platelets in your blood or bleed easily. Especially, tell your health care provider if you take a blood thinner medicine (anticoagulant)
  • Have liver problems
  • Are pregnant or plan to become pregnant, because FASLODEX can harm your unborn baby. Your health care provider may perform a pregnancy test within 7 days before starting FASLODEX. Women who are able to become pregnant should use effective birth control during treatment with FASLODEX and for 1 year after the last dose. Tell your health care provider right away if you become pregnant or think you are pregnant while on FASLODEX
  • Are breastfeeding or plan to breastfeed. It is not known if FASLODEX passes into breast milk. Do not breastfeed during treatment with FASLODEX and for 1 year after the final dose. Talk to your health care provider about the best way to feed your baby during this time

Tell your health care provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. FASLODEX may affect the way other medicines work, and other medicines may affect how FASLODEX works.

FASLODEX is administered by your health care provider as an injection into the muscle of each buttock. Your health care provider may change your dose of FASLODEX if needed.

FASLODEX may cause serious side effects, including injection site–related nerve damage. Call your health care provider if you develop any of the following symptoms in your legs following a FASLODEX injection: numbness, tingling, or weakness.

Common side effects of FASLODEX include injection site pain; nausea; muscle, joint, and bone pain; headache; back pain; tiredness; pain in arms, hands, legs or feet; hot flashes; vomiting; loss of appetite; weakness; cough; shortness of breath; constipation; increased liver enzymes; and diarrhea.

Tell your health care provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with FASLODEX. For more information, ask your health care provider or pharmacist. You may report side effects to the FDA at 1-800-FDA-10881-800-FDA-1088.

Approved Uses for FASLODEX

FASLODEX is a prescription medicine used to treat advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic).

FASLODEX may be used alone, if you have gone through menopause, and your advanced breast cancer is:

  • hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative and has not been previously treated with endocrine therapy

or

  • HR-positive and has progressed after endocrine therapy

FASLODEX may be used in combination with ribociclib, if you have gone through menopause, and your advanced or metastatic breast cancer is HR-positive and HER2-negative, and has not been previously treated with endocrine therapy or has progressed after endocrine therapy.

FASLODEX may be used in combination with palbociclib or abemaciclib if your advanced or metastatic breast cancer is HR-positive and HER2-negative, and has progressed after endocrine therapy.

When FASLODEX is used in combination with palbociclib, abemaciclib or ribociclib, also read the Patient Information for the prescribed product.

It is not known if FASLODEX is safe and effective in children or in people with severe liver problems.

Please see FASLODEX Prescribing Information with Patient Information.